Drug updated on 5/17/2024
Dosage Form | Solution (oral; 100 mg/mL) |
Drug Class | Cannabinoids |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or Tuberous sclerosis complex in patients 1 year of age and older.
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Summary
- Cannabidiol (Epidiolex) is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or Tuberous sclerosis complex in patients 1 year of age and older.
- Twenty studies were reviewed to gather information about this drug.
- Compared to other drugs such as stiripentol and fenfluramine used for treating Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), cannabidiol shows promising outcomes in reducing seizure frequency but may be less effective than these alternatives.
- In pediatric patients with DS, cannabidiol has an acceptable safety profile and offers a significant reduction in seizure frequency, showing substantial efficacy in a subgroup of patients.
- For adult and adolescent patients using cannabidiol as adjunct therapy in focal epilepsy, LGS, or TSC, it showed good efficacy, which varied among different epilepsy subtypes and age groups.
- The safety profile of cannabidiol was generally favorable across studies, with manageable adverse events, including somnolence, decreased appetite, diarrhea, and elevated liver enzymes; however, there was an elevated risk for discontinuation due to adverse reactions when compared to other treatments like stiripentol or fenfluramine.
- Studies emphasize that while cannabidiol is a valuable addition to current therapeutic options for refractory epilepsy syndromes, notably DS and LGS, it might be less effective than some newer drugs like fenfluramine regarding seizure reduction or achieving seizure freedom.
- The potential positive impact of cannabidiol on mental well-being and quality of life remains inconclusive, suggesting a need for further research despite its consistent efficacy across various age groups, including children and adults suffering from DS, LGS, TSC.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Epidiolex (cannabidiol) Prescribing Information. | 2024 | Greenwich Biosciences, Inc., Carlsbad, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Adapted evidence-based clinical practice guidelines for diagnosis and treatment of epilepsies in children: a tertiary Children's Hospital update. | 2023 | Pediatric Neurology |
Medical cannabis for children: Evidence and recommendations. | 2023 | Canadian Paediatric Society |
A practical guide to the treatment of dravet syndrome with anti-seizure medication. | 2022 | CNS Drugs |
Guidance on the use of cannabis-based products for medicinal use in children and young people with epilepsy. | 2021 | British Paediatric Neurology Association |
Epilepsy and cannabidiol: a guide to treatment. | 2020 | Epileptic Disorders |
National Institute for Health and Care Excellence (NICE) guidelines on cannabis-based medicinal products: clinical practice implications for epilepsy management. | 2020 | European Medical Journal |